A Study on Immunotherapy Combined With Radiotherapy for Esophagogastric Junction/Gastric Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJiangsu Cancer Institute & Hospital
About this trial
A single-arm, prospective phase II clinical study of neoadjuvant PD-1/CTLA-4 combination antibody with low-dose radiotherapy in resectable dMMR/MSI-H esophagogastric junction/gastric adenocarcinoma.
Eligibility criteria
Qualifiers
Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and agree to follow-up;
Patients with esophagogastric junction/gastric adenocarcinoma (Siewert type II/III) confirmed by endoscopic pathology (note: pathologies from other hospitals must be reviewed at our hospital), with dMMR/MSI-H status confirmed by immunohistochemistry or genetic testing;
Based on endoscopic, CT, MRI, or PET-CT findings, AJCC 8th edition staging is cT1-2N1-3M0 or T3-T4aN0-3M0;
Age between 18 and 80 years, inclusive of both 18 and 80, both genders are eligible;
Disqualifiers
History of surgery for gastric or gastroesophageal junction tumor;
Immunohistochemistry or genetic testing shows pMMR, MSI-L, or MSS;
High risk of gastrointestinal bleeding or perforation;
Poor nutritional status, BMI < 18.5 kg/m², or PG-SGA score ≥ 9;
Trial design
Treatments tested in this trial
- PD-1/CTLA-4 combination antibody with low-dose radiotherapy
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov